Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery

NCT00539617 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 064511NCI-2011-01276
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the safety and effectiveness of erlotinib and FOLFOX in patients with esophageal or gastro-esophageal cancer that cannot be removed by surgery.

Conditions

Esophageal Cancer

Keywords

metastatic esophageal cancer; erlotinib; folfox; advanced esophageal cancer; unresectable esophageal cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS is defined as the duration of time from enrollment into the run-in period of the study to objective tumor progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. The proportion of patients with PFS will be reported and evaluated using Kaplan-Meier survival curves with median survival and 95% confidence interval.

  Up to 2 years

Secondary Outcomes (2)

• Objective Response Rate (RR)

  Up to 2 years

• Time to Progression (TTP)

  Up to 2 years

Study Arms (1)

Tarceva and FOLFOX

EXPERIMENTAL

COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or no evidence of disease after course 2 or subsequent courses continue on to maintenance phase. MAINTENANCE PHASE: Patients receive erlotinib hydrochloride PO QD on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Erlotinib; Drug: 5-fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

Erlotinib DRUG

Tarceva single agent therapy: 150 mg/day PO

Also known as: Tarceva

Tarceva and FOLFOX

5-fluorouracil DRUG

5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks

Also known as: 5-FU, Adrucil

Tarceva and FOLFOX

Leucovorin DRUG

400 mg/m2 IV once every 2 weeks for 16 weeks

Also known as: Folinic acid

Tarceva and FOLFOX

Oxaliplatin DRUG

85 mg/m2 IV once every 2 weeks for 16 weeks

Also known as: Eloxatin

Tarceva and FOLFOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed esophageal carcinoma (squamous or adenocarcinoma)
• Surgically unresectable disease and/or metastatic disease; endoscopic accessibility of the primary tumor is preferred but not a prerequisite
• No prior chemotherapy therapy except for neoadjuvant treatment (radiation and/or chemotherapy); prior treatment with EGFR-inhibiting agents is not allowed
• Life expectancy \> 12 weeks
• Patients must have the ability to take and retain oral medications or have an appropriate percutaneous feeding tube in place
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky Performance Status (KPS) \>= 50%)
• Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and radiographic imaging performed within 28 days prior to registration
• Absolute neutrophil count (ANC) \>= 1500/mL
• Platelet count \>= 100,000/mL
• Hemoglobin level \>= 10.0 gm/dL
• Serum creatinine =\< 1.5 x IULN (institutional upper limits of normal); OR measured creatinine clearance \>= 60 mL/min
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) or alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) =\< 2.5 x IULN (unless the liver is involved by tumor, in which case it must be =\< 5.0 x IULN)
• Total bilirubin =\< 1.5 x IULN
• Provision of written informed consent
• Women of childbearing potential (WOCBP) must be willing to practice acceptable methods of birth control to prevent pregnancy; WOCBP are any females who have experienced menarche and who have not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who are not postmenopausal (defined as amenorrhea \>= 12 consecutive months), or are on hormone replacement therapy; acceptable methods of birth control include oral or hormonal contraceptives and barrier methods (e.g., condom, diaphragm) used in combination with other methods (e.g., spermicide)

You may not qualify if:

• Presence of a Kras mutation
• Lack of expression of EGFR (tumors that do not have detectable EGFR staining in at least 10% of tumor cells will not be considered EGFR-positive)
• Patients must not be receiving any other investigational agents; use of erythropoietin is allowable; secondary prophylaxis with granulocyte colony stimulating factor (G-CSF) (Filgrastim) is allowable
• The patient concomitantly uses phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort
• Uncontrolled brain metastases
• Patients must not have uncontrolled intercurrent illness at the time of registration including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Patients must not have current New York Heart Association Class III or IV heart disease
• Known human immunodeficiency virus (HIV) infection
• Pregnant or breast-feeding women
• Patients who have had prior malignancies, except non-melanoma skin cancer (basal or squamous cell carcinoma) are not eligible for this study; unless greater than 5 years has passed since the event
• Known severe hypersensitivity to Tarceva
• Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment
• Incomplete healing from previous oncologic or other major surgery
• Serum creatinine level greater than Common Toxicity Criteria (CTC) grade 2

Sponsors & Collaborators

• University of California, San Francisco: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Erlotinib Hydrochloride; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Limitations and Caveats

Early termination due to low accrual resulting in a sample size insufficient to conduct reliable analyses

Results Point of Contact

• Title: W. Michael Korn, MD
• Organization: University of California, San Francisco

michael.korn@ucsf.edu

415-502-2844

Study Officials

• W. Michael Korn, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 4, 2007
• Study Start: October 5, 2007
• Primary Completion: May 12, 2011
• Study Completion: May 12, 2011
• Last Updated: March 23, 2020
• Results First Posted: October 12, 2012

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)